Z-1842-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- April 26, 2018
- Termination Date
- June 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 171,271 units in total
Product Description
(1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183) (2) KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 (Item Number: KIT-DE-0083,KIT-DE-0083 APPENEKTOMIE KIT NAUENX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.
Reason for Recall
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Distribution Pattern
Worldwide and US Nationwide
Code Information
Lot Numbers (1) 0214014173, 0214573291, 0214621781, 0214909631, 0215068744,0215068743, 0215108744, 0215108743, 0215276369 (2)0214798114,0214618312, 0214795633,0215002022,0215010930, 0215010931,0215010932,0215132611,0215132612,0215132613, 0215264173